Introduction to Modern Liquid Chromatography, Third Edition part 3. High-performance liquid chromatography (HPLC) is today the leading technique for chemical analysis and related applications, with an ability to separate, analyze, and/or purify virtually any sample. Snyder and Kirkland's Introduction to Modern Liquid Chromatography has long represented the premier reference to HPLC. This Third Edition, with John Dolan as added coauthor, addresses important improvements in columns and equipment, as well as major advances in our understanding of HPLC separation, our ability to solve problems that were troublesome in the past, and the application of HPLC for new kinds of samples. . | xviii CONTENTS Lower Limit of Quantification LLOQorLOQ 514 Upper Limits 515 Samples Outside Limits 515 Qualitative Analysis 516 RetentionTime .6 On-line Qualitative Analysis 517 UVDetection 5n8 LC-MS 518 L8-FTIFI 519 513 Detector tCLN si0 Detector TLgSDg 5a9 Cgira-Detectors 519 0ff-Vi D A9aIy5is 5L9 Quantitative Analysis 520 Calibration .20 External StaiDardiration 520 .ete-nal 523 AreaNormalizLtion 522 . AtandaTd Addition 526 . SEvalaatitg Gilibration Curve. 527 Trace Summary 529 References 529 12 METHOD VALIDATION 531 with Michael Swart. lntn-Duction 582 TntmsandDefirkions 534 Accuracy 5t5 AreiNicy 536 Repeatability 536 Precision 537 537 Ruggednnsn 538 Sp-cificity. .3. Limit of ancKimitof QuantifiraV- -1 e-9 Linearity tv--Rvege moo RobustneTSl5Vo CONTENTS xix System Suitability 542 Documentation 543 Validation Protocol 544 Test Method 544 Validation Report 545 Va lidati onforDifferentPharmaceutical-Method Types 546 Category iMetfiods 6 Category 2Methodo 54c Category iMenh6ds 547 a CatngotyZiMethodd0 548 BioanalytifalMetfcods 548 ReferanceSthndard Preparetio4 549 Bio5n2lytinolMethep l drlopment and Validatioe hg6 ShlectMty 5150 Achoraey Precision and R ovenf o 6nlinration ptad6or4Cur6e 55d u5i Routine Applicntinn o oftoanuh tioal Method 552 Bioanalyti .a. MetaoeDocum6dtntion o 3 Analytical Method Tra2sfor AMT 554 Analytical Method-TnansferOptions 555 Comuaraaiv2Te6tmR 555 Co-ooUdation between .